DreamPort-Eclipse: Compact, ultra-low contact, custom fit CPAP human interface solution for obstructive sleep apnea

DreamPort-Eclipse：紧凑、超低接触、定制的 CPAP 人机界面解决方案，用于治疗阻塞性睡眠呼吸暂停

• 批准号: 10323209
• 负责人: Stuart Heatherington
• 金额: $ 86.06万
• 依托单位: BLEEP, LLC
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-22 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10323209
• 关键词: Academy; Accidents; Address; Adhesives; Adoption; Air; Air Pressure; American; Anterior nares; Apnea; Chronic; Chronic Disease; Clinical; Code; Continuous Positive Airway Pressure; Custom; Development; Devices; Diabetes Mellitus; Diagnosis; Durable Medical Equipment; Effectiveness; Engineering; Extravasation; Face; Feedback; Foundations; Generations; Health Care Costs; Healthcare; Healthcare Common Procedure Coding System; Heart Diseases; Home; Hour; Human; Hypertension; Individual; Intellectual Property; Magnetism; Manufacturer Name; Masks; Mechanics; Medicine; Mental Depression; Middle Insomnia; Modification; Motor Vehicles; Newly Diagnosed; Nose; Obstructive Sleep Apnea; Outcome; Pain; Participant; Patient-Focused Outcomes; Patients; Penetration; Performance; Phase; Positioning Attribute; Productivity; Quality of life; Randomized Controlled Trials; Reaction; Research; Respiration Disorders; Risk; Sleep; Sleep Apnea Syndromes; Small Business Innovation Research Grant; Stream; Symptoms; Technology; Testing; Time; Titrations; United States National Institutes of Health; Update; Validation; Weight; Workplace; adherence rate; barrier to care; base; cost; design; effective therapy; effectiveness evaluation; experience; face mask; field study; improved; indexing; innovation; light weight; new technology; next generation; non-compliance; novel; preference; pressure; programs; prototype; seal; sleep quality; success; traditional therapy; treatment duration; usability

PROJECT SUMMARY Approximately 40 million people in the U.S. and 938 million globally are diagnosed with obstructive sleep apnea (OSA) and could benefit from continuous positive airway pressure (CPAP) therapy. The largest barrier to treatment is the archaic design strategy for masks, which causes as many as 50% of individuals using CPAP therapy to become noncompliant within the first 30 days of treatment. Patients cite reasons for noncompliance such as discomfort, pain, ill-fitting headgear, face marks, leaks, and claustrophobic reactions. Untreated sleep apnea limits productivity, increases motor vehicle and workplace accidents, and increases risk of costly chronic healthcare conditions such as hypertension, heart disease, diabetes, and depression. Healthcare costs for those with OSA not treated by CPAP therapy can exceed $5,000 over those receiving treatment. The innovative DreamPort technology is positioned to create a dramatic market shift in CPAP compliance, as it removes traditional headgear, addresses major concerns to current masks, and delivers effective treatment. The DreamPort uses small, lightweight adhesives to seal around nostrils with an ergonomic design that accommodates unique human profiles of individuals. It completes an ideal mechanical circuit for CPAP therapy to deliver pressure to the airway and stabilize users’ disordered breathing during sleep. Since the initial soft launch of the first generation DreamPort in early 2019, rapid market penetration has been achieved in both the direct to consumer and HME/DME spaces with over 5,000 patients currently using DreamPort. The current platform is FDA 510k cleared to market with established billing codes (CMS HCPCS codes) and issued intellectual property protection. While early feasibility and market adoption have been successfully demonstrated, several technical updates will optimize user experience and derived sleep quality. More specifically, this Direct to Phase II project will leverage our existing DreamPort mask technology as a strong foundation to increase likelihood of success, with continued development focusing on several key design enhancements to optimize setup, comfort, and compatibility. The DreamPort-Eclipse platform will simplify the human interface connection through an innovative magnetic connection between nostril adhesive and connector. Furthermore, the device profile and weight will be reduced and optimized for integration with a larger number of CPAP device manufacturers. User setup workflows will also be ergonomically updated to minimize barriers to adoption. Once the prototype passes all engineering bench testing, it will be deployed in a simulated in-house usability study. Continued development will target final design modifications based on preliminary user feedback, and full-scale validation testing as per regulatory standards. Finally, we will conduct a randomized controlled trial to assess the effectiveness of the DreamPort-Eclipse on leak, AHI, and pressure compared to the first-generation DreamPort and the traditional nasal mask.

项目摘要 美国约有4000万人和全球9.38亿人被诊断出患有阻塞性睡眠 呼吸暂停（OSA），可以从连续的阳性气道压力（CPAP）疗法中受益。最大的障碍 治疗是面具的古老设计策略，它会导致多达50％的使用CPAP的个体 在治疗的前30天内将其变为不合格。患者引用不符合违规的原因 例如不适，疼痛，不合适的头饰，面部标记，泄漏和幽闭恐惧症反应。未经治疗的睡眠 呼吸暂停会限制生产率，增加机动车和工作场所事故，并增加昂贵的慢性风险 高血压，心脏病，糖尿病和抑郁症等医疗保健状况。那些人的医疗保健费用 在接受CPAP治疗的OSA中，与接受治疗的人相比，OSA可以超过5,000美元。 创新的DreamPort技术定位，可以在CPAP合规性中造成巨大的市场转变， 由于它可以删除传统的头饰，因此解决了当前面具的主要问题，并提供有效的治疗方法。 Dreamport使用小型，轻巧的胶粘剂，以符合人体工程学设计的设计围绕鼻孔密封 适应个人的独特人类概况。它完成了CPAP治疗的理想机械电路 向气道施加压力，并在睡眠期间稳定用户的呼吸无序。由于最初的柔软 在2019年初推出了第一代Dreamport，这两者都达到了快速的市场渗透率 直接直接使用目前使用Dreamport的5,000多名患者的消费者和HME/DME空间。电流 平台通过既定的计费代码（CMS HCPC代码）将FDA 510K清除到市场上 知识产权保护。尽管已成功证明了早期的可行性和市场采用率 几项技术更新将优化用户体验和衍生的睡眠质量。 更具体地说，直接到II期项目将利用我们现有的Dreamport面具技术作为一种 强大的基础以增加成功的可能性，继续开发着重于几种关键设计 增强功能以​​优化设置，舒适性和兼容性。 Dreamport-ceclipse平台将简化 人界面通过鼻孔粘合剂和连接器之间的创新磁连接连接。 此外，将减少和优化设备轮廓和重量以与较大数量的集成 CPAP设备制造商。用户设置工作流程也将通过人体工程学更新，以最大程度地减少 采用。原型通过所有工程台式测试后，它将部署在模拟的内部 可用性研究。持续开发将基于初步用户反馈，针对最终设计修改， 按照法规标准进行全尺度验证测试。最后，我们将进行随机对照试验 与第一代相比 Dreamport和传统的鼻面膜。